Goals

S&T Objectives Overview:

The Custom-IMD project will develop new biomaterials for the manufacture of innovative fully customised medical implants using enhanced rapid manufacturing technologies; achieving implant design, manufacture, sterilisation, regulatory approval and delivery to the surgeon within a 48 hour time frame. The fundamental project research areas will include:

Extended Services

Biomaterials	Rapid Manufacturing	Biocompatibility
E-supply chain integration	Implant Development
High added value	Sustainability & Eco-efficiency

The core project objectives are:

The development of innovative biomaterials (ceramics, bio-passive, bio-active and shape-memory polymers) for use in Rapid Manufacturing achieving bio-mimicking properties (anisotropic, bio-active).
To undertake in-vitro, cell culture and in-vivo animal studies for the new biomaterials; thus generating a strong toxicological and biocompatibility knowledge base.
To achieve innovations within 5 Rapid Manufacturing techniques (Continuous 3D Printing, Fused Deposition Modelling, Laser Sintering Direct Laser Forming and Indirect Rapid Manufacture) enabling the processing of the selected bio-materials achieving targeted material properties (bio-mimic for selected application) and timeframe (enabling completion of supply chain within 48 hours).
To achieve integration of the medically certified e-supply chain management (confidential patient data, material supply, implant design and manufacture, sterilisation and regulatory approval) enabling customised implants to be supplied to the surgeon within a target timeframe of 48 hours.
The design, manufacture and testing of three fully customisable implant products (craniofacial bone plate; lumbar spinal disc prosthesis; and dental restoration) achieving target implant specifications.
To demonstrate the direct economic savings to the European healthcare service for customisable implants (target: 20% healthcare savings in comparison with non-customised implants); and to quantify their wider economic and societal added value.

The project objectives demonstrate high relevance to the NMP objectives, including: industrial transformation towards high-tech / knowledge based processes and products; higher added value (economic competitiveness); the generation of new knowledge; and greater European integration (across science, industry and society).

Project Objectives

The 2010 industry paradigm will be that the surgeon will execute surgical operations using fully customised implants, designed solely on the clinical needs of the patient. This vision will be realised through the development of new biomaterials for the manufacture of innovative fully customised medical implants using enhanced rapid manufacturing technologies; achieving implant design, manufacture, sterilisation, regulatory approval and delivery to the surgeon within a 48 hour time frame. The fundamental project research areas will include:

Biomaterials	Rapid Manufacturing	Biocompatibility
E-supply chain integration	Implant Development	Extended Services
High added value	Sustainability & Eco-efficiency

The project will directly address the needs of European high-tech SMEs and will employ an objective driven approach to achieve focused breakthroughs and innovations throughout the SME implant added value chain:

Industrial Transformation Breakthroughs:

A reduction in the customisable implant supply chain to within a 48 hour timeframe.
To develop new European biomaterials with new characteristics (bio-mimic properties).
Development and Implementation of five �Rapid Manufacturing� (RM) techniques into industry for the newly developed biomaterials (from resource-based to knowledge-based manufacturing).
To move from mass produced identical products to new concepts of custom made, eco-efficient and sustainable products, achieving higher economic added value and greater competitiveness.
To achieve the critical mass of data for key biomaterials to provide support and confidence to industry to seek product regulatory approval / certification for implants manufactured using the new biomaterials.

Main Scientific Breakthroughs:

New biomaterials with bio-mimic properties (e.g. anisotropic, bio-active) demonstrated within dental, craniofacial and spinal applications.
Integration of customised implant e-supply chain management (confidential patient data, material supply, implant design and manufacture, sterilisation and regulatory compliance).
Innovations within Rapid Manufacturing techniques enabling the processing of the new biomaterials materials resulting in new concepts of product design achieving higher �added value� (e.g. drug delivery, porosity, coatings, biocompatible and bio-active properties).
Enhanced material properties for shape-memory polymers, enabling minimally invasive spinal implants.

Societal Breakthroughs:

Patient healthcare provision of fully customised implants within 48 hours, achieving patient added value (quality of life, less patient discomfort, better functionality, and patient rehabilitation).
A 20% overall reduction in European Implant Healthcare Costs (hospitalisation and patient productivity; healthcare insurance; surgical effectiveness; and patient rehabilitation).

Need for Project: Industry

Pressure from lower cost manufacturing in Asia and technological developments in the US; Lack of available biomaterials within the EU suitable for use in combination with rapid manufacturing techniques (requirement for the critical mass in research, regulatory approval and market demand); Need to development the RM technologies for use of the new materials; Provision of education and training to SMEs for take-up of the project results (technical and regulatory support); Limitation of existing implant products (bio-mimicking properties); and Greater European integration of the medical device value chain (improved efficiency and lower cost).

Need for Project: Healthcare

Patient pressure for implants with improved aesthetics, performance and lifetime; and Pressure for greater European healthcare efficiency[1] (aging European population with a higher dependence on medical device technologies).

Why Customisation:

Customisation enables greater structural, functional and biological biocompatibility with the patient, enabling longer implant life-times; improved aesthetics, performance and patient comfort leading to improved quality of life; and often enable quicker and less invasive surgical operations; thus demonstrating higher-added value.

Why an IP-SME:

The medical implant sector comprises 80% SME industries[2] operating mainly independently within niche market sectors. Facing increasing pressure from abroad and large multinational organisations; it is essential that SME industries are able to integrate their specialist expertise, technologies and services, and new knowledge, biomaterials and technologies; thus transforming the SME implant value chain towards greater sustainability and competitiveness.

Economic Impact:

The widespread introduction of customisable implants has been estimated to penetrate the implant market by �1.6 billion euros over an eight year period, creating over 20,000 new jobs in Europe. The Custom-IMD consortium intends to achieve an annual 5% (�80 million) share of this market within an eight year timeframe, generating over 1000 new jobs.